MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 LGX MS PUMP; PROSTHESIS, PENIS, INFLATABLE

Model Number	72404253
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon receipt of this inflatable penile prosthesis at our quality assurance laboratory, this device was thoroughly analyzed.Microscopic analysis identified first cylinder had a hole in the outer tube from sharp instrument damage in the distal end of the cylinder.The second cylinder did not present any damage or abnormalities.The microscopic pump analysis identified there were no damage or abnormalities found.The device was tested too.Both cylinders successfully passed leakage test.The pump was also tested, concluding that the pump passed leakage and functional tests.Even the sharp instrument damage was found on the device, this was considered a secondary failure; the primary allegation of a mechanical issue was unable to be confirmed.Based on the information provided, cause not established was selected as the most probable cause for the complaint.
Event or Problem Description
It was reported that the inflatable penile prosthesis (ipp) was implanted on (b)(6) 2025.Then, the pump presented a filling defect.The device returned to be analyzed, indicating there was a surgical procedure performed to explant the device.

• Brand Name: AMS 700 LGX MS PUMP
• Common Device Name: PROSTHESIS, PENIS, INFLATABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: farshad fahimi fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22342520
• Report Number: 2124215-2025-41757
• Device Sequence Number: 4901954
• Product Code: JCW
• UDI-Device Identifier: 00878953003610
• UDI-Public: (01)00878953003610(17)260919(10)1100594614
• Combination Product (Y/N): Y
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/19/2026
• Device Model Number: 72404253
• Device Catalogue Number: 72404253
• Device Lot Number: 1100594614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown